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Evoxac (Cevimeline Hydrochloride) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

Cevimeline was administered to 1777 patients during clinical trials worldwide, including Sjögren’s patients and patients with other conditions. In placebo-controlled Sjögren’s studies in the U.S., 320 patients received cevimeline doses ranging from 15 mg tid to 60 mg tid, of whom 93% were women and 7% were men. Demographic distribution was 90% Caucasian, 5% Hispanic, 3% Black and 2% of other origin. In these studies, 14.6% of patients discontinued treatment with cevimeline due to adverse events.

The following adverse events associated with muscarinic agonism were observed in the clinical trials of cevimeline in Sjögren’s syndrome patients:

Adverse Event Cevimeline 30mg (tid)   n*= 533 Placebo  (tid)    n = 164



Excessive Sweating 18.7% 2.4%
Nausea 13.8% 7.9%
Rhinitis 11.2% 5.4%
Diarrhea 10.3% 10.3%
Excessive Salivation 2.2% 0.6%
Urinary Frequency 0.9% 1.8%
Asthenia 0.5% 0.0%
Flushing 0.3% 0.6%
Polyuria 0.1% 0.6%
*n is the total number of patients exposed to the dose at any time during the study.

Adverse Event Cevimeline 30mg (tid)   n*=533 Placebo  (tid)    n=164



Headache 14.4% 20.1%
Sinusitis 12.3% 10.9%
Upper Respiratory Tract Infection 11.4% 9.1%
Dyspepsia 7.8% 8.5%
Abdominal Pain 7.6% 6.7%
Urinary Tract Infection 6.1% 3.0%
Coughing 6.1% 3.0%
Pharyngitis 5.2% 5.4%
Vomiting 4.6% 2.4%
Injury 4.5% 2.4%
Back Pain 4.5% 4.2%
Rash 4.3% 6.0%
Conjunctivitis 4.3% 3.6%
Dizziness 4.1% 7.3%
Bronchitis 4.1% 1.2%
Arthralgia 3.7% 1.8%
Surgical Intervention 3.3% 3.0%
Fatigue 3.3% 1.2%
Pain 3.3% 3.0%
Skeletal Pain 2.8% 1.8%
Insomnia 2.4% 1.2%
Hot Flushes 2.4% 0.0%
Rigors 1.3% 1.2%
Anxiety 1.3% 1.2%
*n is the total number of patients exposed to the dose at any time during the study.

The following events were reported in Sjögren’s patients at incidences of less than 3% and ≥1%: constipation, tremor, abnormal vision, hypertonia, peripheral edema, chest pain, myalgia, fever, anorexia, eye pain, earache, dry mouth, vertigo, salivary gland pain, pruritus, influenza-like symptoms, eye infection, post-operative pain, vaginitis, skin disorder, depression, hiccup, hyporeflexia, infection, fungal infection, sialoadenitis, otitis media, erythematous rash, pneumonia, edema, salivary gland enlargement, allergy, gastroesophageal reflux, eye abnormality, migraine, tooth disorder, epistaxis, flatulence, toothache, ulcerative stomatitis, anemia, hypoesthesia, cystitis, leg cramps, abscess, eructation, moniliasis, palpitation, increased amylase, xerophthalmia, allergic reaction.

The following events were reported rarely in treated Sjögren’s patients (less than 1%): Causal relation is unknown:

Body as a Whole Disorders: aggravated allergy, precordial chest pain, abnormal crying, hematoma, leg pain, edema, periorbital edema, activated pain trauma, pallor, changed sensation temperature, weight decrease, weight increase, choking, mouth edema, syncope, malaise, face edema, substernal chest pain

Cardiovascular Disorders: abnormal ECG, heart disorder, heart murmur, aggravated hypertension, hypotension, arrhythmia, extrasystoles, t wave inversion, tachycardia, supraventricular tachycardia, angina pectoris, myocardial infarction, pericarditis, pulmonary embolism, peripheral ischemia, superficial phlebitis, purpura, deep thrombophlebitis, vascular disorder, vasculitis, hypertension

Digestive Disorders: appendicitis, increased appetite, ulcerative colitis, diverticulitis, duodenitis, dysphagia, enterocolitis, gastric ulcer, gastritis, gastroenteritis, gastrointestinal hemorrhage, gingivitis, glossitis, rectum hemorrhage, hemorrhoids, ileus, irritable bowel syndrome, melena, mucositis, esophageal stricture, esophagitis, oral hemorrhage, peptic ulcer, periodontal destruction, rectal disorder, stomatitis, tenesmus, tongue discoloration, tongue disorder, geographic tongue, tongue ulceration, dental caries

Endocrine Disorders: increased glucocorticoids, goiter, hypothyroidism

Hematologic Disorders: thrombocytopenic purpura, thrombocythemia, thrombocytopenia, hypochromic anemia, eosinophilia, granulocytopenia, leucopenia, leukocytosis, cervical lymphadenopathy, lymphadenopathy

Liver and Biliary System Disorders: cholelithiasis, increased gamma-glutamyl transferase, increased hepatic enzymes, abnormal hepatic function, viral hepatitis, increased serum glutamate oxaloacetic transaminase (SGOT) (also called AST-aspartate aminotransferase), increased serum glutamate pyruvate transaminase (SGPT) (also called ALT-alanine aminotransferase)

Metabolic and Nutritional Disorders: dehydration, diabetes mellitus, hypercalcemia, hypercholesterolemia, hyperglycemia, hyperlipemia, hypertriglyceridemia, hyperuricemia, hypoglycemia, hypokalemia, hyponatremia, thirst

Musculoskeletal Disorders: arthritis, aggravated arthritis, arthropathy, femoral head avascular necrosis, bone disorder, bursitis, costochondritis, plantar fasciitis, muscle weakness, osteomyelitis, osteoporosis, synovitis, tendinitis, tenosynovitis

Neoplasms: basal cell carcinoma, squamous carcinoma

Nervous Disorders: carpal tunnel syndrome, coma, abnormal coordination, dysesthesia, dyskinesia, dysphonia, aggravated multiple sclerosis, involuntary muscle contractions, neuralgia, neuropathy, paresthesia, speech disorder, agitation, confusion, depersonalization, aggravated depression, abnormal dreaming, emotional lability, manic reaction, paroniria, somnolence, abnormal thinking, hyperkinesia, hallucination

Miscellaneous Disorders: fall, food poisoning, heat stroke, joint dislocation, post-operative hemorrhage

Resistance Mechanism Disorders: cellulitis, herpes simplex, herpes zoster, bacterial infection, viral infection, genital moniliasis, sepsis

Respiratory Disorders: asthma, bronchospasm, chronic obstructive airway disease, dyspnea, hemoptysis, laryngitis, nasal ulcer, pleural effusion, pleurisy, pulmonary congestion, pulmonary fibrosis, respiratory disorder

Rheumatologic Disorders: aggravated rheumatoid arthritis, lupus erythematosus rash, lupus erythematosus syndrome

Skin and Appendages Disorders: acne, alopecia, burn, dermatitis, contact dermatitis, lichenoid dermatitis, eczema, furunculosis, hyperkeratosis, lichen planus, nail discoloration, nail disorder, onychia, onychomycosis, paronychia, photosensitivity reaction, rosacea, scleroderma, seborrhea, skin discoloration, dry skin, skin exfoliation, skin hypertrophy, skin ulceration, urticaria, verruca, bullous eruption, cold clammy skin

Special Senses Disorders: deafness, decreased hearing, motion sickness, parosmia, taste perversion, blepharitis, cataract, corneal opacity, corneal ulceration, diplopia, glaucoma, anterior chamber eye hemorrhage, keratitis, keratoconjunctivitis, mydriasis, myopia, photopsia, retinal deposits, retinal disorder, scleritis, vitreous detachment, tinnitus

Urogenital Disorders: epididymitis, prostatic disorder, abnormal sexual function, amenorrhea, female breast neoplasm, malignant female breast neoplasm, female breast pain, positive cervical smear test, dysmenorrhea, endometrial disorder, intermenstrual bleeding, leukorrhea, menorrhagia, menstrual disorder, ovarian cyst, ovarian disorder, genital pruritus, uterine hemorrhage, vaginal hemorrhage, atrophic vaginitis, albuminuria, bladder discomfort, increased blood urea nitrogen, dysuria, hematuria, micturition disorder, nephrosis, nocturia, increased nonprotein nitrogen, pyelonephritis, renal calculus, abnormal renal function, renal pain, strangury, urethral disorder, abnormal urine, urinary incontinence, decreased urine flow, pyuria

In one subject with lupus erythematosus receiving concomitant multiple drug therapy, a highly elevated ALT level was noted after the fourth week of cevimeline therapy. In two other subjects receiving cevimeline in the clinical trials, very high AST levels were noted. The significance of these findings is unknown.

Additional adverse events (relationship unknown) which occurred in other clinical studies (patient population different from Sjögren’s patients) are as follows:

cholinergic syndrome, blood pressure fluctuation, cardiomegaly, postural hypotension, aphasia, convulsions, abnormal gait, hyperesthesia, paralysis, abnormal sexual function, enlarged abdomen, change in bowel habits, gum hyperplasia, intestinal obstruction, bundle branch block, increased creatine phosphokinase, electrolyte abnormality, glycosuria, gout, hyperkalemia, hyperproteinemia, increased lactic dehydrogenase (LDH), increased alkaline phosphatase, failure to thrive, abnormal platelets, aggressive reaction, amnesia, apathy, delirium, delusion, dementia, illusion, impotence, neurosis, paranoid reaction, personality disorder, hyperhemoglobinemia, apnea, atelectasis, yawning, oliguria, urinary retention, distended vein, lymphocytosis

The following adverse reaction has been identified during post-approval use of EVOXAC®. Because post-marketing adverse reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Post-marketing Adverse Events

Liver and Biliary System Disorders: cholecystitis


MANAGEMENT OF OVERDOSE

Management of the signs and symptoms of acute overdosage should be handled in a manner consistent with that indicated for other muscarinic agonists: general supportive measures should be instituted. If medically indicated, atropine, an anti-cholinergic agent, may be of value as an antidote for emergency use in patients who have had an overdose of cevimeline. If medically indicated, epinephrine may also be of value in the presence of severe cardiovascular depression or bronchoconstriction. It is not known if cevimeline is dialyzable.



REPORTS OF SUSPECTED EVOXAC SIDE EFFECTS / ADVERSE REACTIONS

Below is a sample of reports where side effects / adverse reactions may be related to Evoxac. The information is not vetted and should not be considered as verified clinical evidence.

Possible Evoxac side effects / adverse reactions in 72 year old female

Reported by a consumer/non-health professional from United States on 2012-01-10

Patient: 72 year old female weighing 76.2 kg (167.6 pounds)

Reactions: Pain in Extremity, Musculoskeletal Pain, Myalgia, Neck Pain, NO Therapeutic Response, Tooth Disorder, Neuralgia, Muscle Spasms

Suspect drug(s):
Evoxac
    Dosage: 30
    Administration route: Oral
    Indication: Sjogren's Syndrome
    Start date: 2011-12-22
    End date: 2012-01-06

Evoxac
    Dosage: 30
    Administration route: Oral
    Indication: DRY Mouth
    Start date: 2011-12-22
    End date: 2012-01-06



Possible Evoxac side effects / adverse reactions in 65 year old female

Reported by a individual with unspecified qualification from United States on 2012-02-22

Patient: 65 year old female weighing 46.3 kg (101.8 pounds)

Reactions: Glaucoma, Eye Irritation

Suspect drug(s):
Restasis
    Dosage: ophthalmic
    Indication: Glaucoma

Evoxac
    Dosage: 90 mg (30 mg,tid),per oral ; 60 mg (30 mg,bid),per oral
    Administration route: Oral
    Indication: Sjogren's Syndrome
    Start date: 2010-12-01

Evoxac
    Dosage: 90 mg (30 mg,tid),per oral ; 60 mg (30 mg,bid),per oral
    Administration route: Oral
    Indication: Sjogren's Syndrome
    Start date: 2002-04-08
    End date: 2010-12-01

Other drugs received by patient: Lorazepam (Lorazepam) (Tablet) (Lorazepam); Zyrtec (Cetirizine Hydrochloride) (Tablet) (Cetirizine Hydrochloride); I-Flora Probiotic (Lactobacillus Reuteri) (Lactobacillus Reuteri); Sertraline (Sertraline) (Tablet) (Sertraline); Fiber Supplement (Polycarbophil Calcium) (Polycarbophil Calcium)



Possible Evoxac side effects / adverse reactions in 73 year old female

Reported by a physician from United States on 2012-02-22

Patient: 73 year old female

Reactions: Atrioventricular Block

Suspect drug(s):
Evoxac

Other drugs received by patient: Fosamax; Plaquenil (Hydroxychloroquine) (Hydroxychloroquine)



See index of all Evoxac side effect reports >>

Drug label data at the top of this Page last updated: 2011-08-02

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